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Claims for Patent: 5,814,600

Claims for Patent: 5,814,600

Title:

Method and composition for treatment of insulin requiring mammals

Abstract:

Method and compositions for treating a mammal by administering to that mammal an insulin (having the in vitro activity of stimulating glucose incorporation into glycogen in rat soleus muscle) and an amylin (having the in vitro activity of suppressing glucose incorporation into glycogen in rat soleus muscle) using specific molar ratios of an insulin to an amylin.

Inventor(s):

Rink; Timothy J. (La Jolla, CA), Young; Andrew A. (Alpine, CA)

Assignee:

Amylin Pharmaceuticals Inc. (San Diego, CA)

Application Number:

08/259,762

Patent Claims:

1. A method of treating a mammal having a need for, or a reduced ability to produce, insulin, comprising administering to said mammal an insulin having an in vitro activity of
stimulating glucose incorporation into glycogen in rat soleus muscle, and an amylin having the in vitro activity of suppressing glucose incorporation into glycogen in rat soleus muscle, wherein said insulin and said amylin are administered in a molar
ratio of between about 1:1 and about 67:1.

2. A method according to claim 1 wherein said method further comprises identifying a mammal having a reduced ability to produce serum insulin compared to the normal ability of said mammal to produce serum insulin.

3. A method according to claim 1 wherein said insulin and said amylin are administered in a molar ratio of between about 7:1 and about 67:1.

4. A method according to claim 1 wherein said insulin and said amylin are administered in a molar ratio of between about 1:1 to about 40:1.

5. A method according to claim 4 wherein said insulin and said amylin are administered in a molar ratio of between about 2.5:1 and about 35:1.

6. A method according to claim 4 wherein said insulin and said amylin are administered in a molar ratio of between about 5:1 and about 25:1.

7. A method according to claim 4 wherein said insulin and said amylin are administered in a molar ratio of between about 5:1 and about 10:1.

8. A method according to claim 4 wherein said insulin and said amylin are administered in a molar ratio of between about 4:1 and about 10:1.

9. A method according any of claims 1-8 wherein said amylin comprises .sup.25,28,29 Pro-human amylin.

10. A method according to any of claims 1-5 or 6-8 wherein said amylin comprises .sup.25,28,29 Pro-human amylin and said mammal is a human.

11. A method according to any of claims 1-5 or 6-8 wherein said amylin comprises .sup.25,28,29 Pro-human amylin and said mammal is a human suffering from diabetes mellitus.

12. A method according to claim 1 wherein said amylin is administered in an amount of at least about 0.2 micrograms per kilogram of said mammal per day.

13. A method according to claim 1 wherein said amylin is administered in an amount of at least about 0.4 micrograms per kilogram of said mammal per day.

14. A method according to claim 1 wherein said amylin is administered in an amount of at least about 0.5 micrograms per kilogram of said mammal per day.

15. A method according to claim 1 wherein said amylin is administered in an amount of between about 0.2 micrograms per kilogram of said mammal per day and about 5 micrograms per kilogram of said mammal per day.

16. A method according to claim 15 wherein said amylin is administered in an amount of between about 0.4 micrograms per kilogram of said mammals per day and about 2 micrograms per kilogram of said mammal per day.

17. A method according to any of claims 12-16 wherein said amylin comprises .sup.25,28,29 Pro-human amylin.

18. A method according to any of claims 12-16 wherein said amylin comprises 25,28,29Pro-human amylin and said mammal is a human.

19. A method according to any of claims 12-16 wherein said amylin comprises .sup.25,28,29 Pro-human amylin and said mammal is a human suffering from diabetes.

20. A method according to claim 1 wherein said mammal is a human suffering from diabetes and said amylin is administered in an amount of at least about 90 micrograms per day.

22. A method of treating a mammal having a need for, or a reduced ability to produce, insulin, comprising administering to said mammal a composition comprising an insulin having an in vitro activity of stimulating glucose incorporation into
glycogen in rat soleus muscle, and an amylin having the in vitro activity of suppressing glucose incorporation into glycogen in rat soleus muscle, wherein said insulin and said amylin are administered in a suitable molar ratio such that, upon
administration of such composition to said mammal, the amount of said amylin said composition will result in plasma levels of amylin of about 3% to about 6% the plasma levels of insulin.

23. A method of treating a mammal having a need for, or a reduced ability to produce, insulin, comprising administering to said mammal a composition comprising an insulin having an in vitro activity of stimulating glucose incorporation into
glycogen in rat soleus muscle, and an amylin having the in vitro activity of suppressing glucose incorporation into glycogen in rat soleus muscle, wherein said insulin and said amylin are administered in a suitable molar ratio such that, upon
administration of such composition to said mammal, the amount of said amylin in said composition will result in plasma levels of amylin of about 4% to about 7% the plasma levels of insulin.

24. A method according to either of claims 22 or 23 wherein said amylin comprises .sup.25,28,29 Pro-human amylin and said mammal is a human.

25. A composition comprising an insulin having an in vitro activity of stimulating glucose incorporation into glycogen in rat soleus muscle, and an amylin having the in vitro activity of suppressing glucose incorporation into glycogen in rat
soleus muscle, wherein said insulin and said amylin are provided in a molar ratio of between about 1:1 and about 67:1.

26. A composition according to claim 25 wherein said insulin and said amylin are provided at a molar ratio of between about 7:1 and about 67:1.

27. A composition according to claim 25 wherein said insulin and said amylin are provided at a molar ratio of between about 1:1 to about 40:1.

28. A composition according to claim 27 wherein said insulin and said amylin are provided at a molar ratio of between about 2.5:1 and about 35:1.

29. A composition according to claim 27 wherein said insulin and said amylin are provided at a molar ratio of between about 5:1 and about 25:1.

30. A composition according to claim 27 wherein said insulin and said amylin are provided at a molar ratio of between about 5:1 and about 10:1.

31. A composition according to claim 27 wherein said insulin and said amylin are provided at a molar ratio of between about 4:1 and about 10:1.

32. A composition according to any of claims 25-31 wherein said amylin comprises .sup.25,28,29 Pro-human amylin.

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